LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [NUCARE PHARMACEUTICALS,INC.]

LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [NUCARE PHARMACEUTICALS,INC.]
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NDC	68071-4762-2
Set ID	81b4deec-fe5f-b0f9-e053-2991aa0a1c54
Category	HUMAN OTC DRUG LABEL
Packager	NuCare Pharmaceuticals,Inc.
Generic Name
Product Class
Product Number
Application Number	PART343

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ACTIVE INGREDIENT
INACTIVE INGREDIENT
DOSAGE & ADMINISTRATION
INDICATIONS & USAGE
WARNINGS
PURPOSE
KEEP OUT OF REACH OF CHILDREN
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOW DOSE ASPIRIN
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68071-4762(NDC:49483-481)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	HEART
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68071-4762-2	120 in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	06/19/2015

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Name	Address	ID/FEI	Business Operations
Establishment
NuCare Pharmaceuticals,Inc.		010632300	relabel(68071-4762)

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